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With this breakthrough designation and alignment with the FDA on registrational Phase 3 trial parameters, we are laser-focused on strengthening the foundation of Altimmune to advance pemvidutide through late-stage development guided by our commitment to serve patients and create value for our stakeholders." Breakthrough Therapy Designation for pemvidutide in MASH was granted based on submission of 24-week data from the IMPACT Phase 2b trial demonstrating statistically significant MASH resolution without worsening of fibrosis, along with early and substantial improvements in liver fat and non-invasive tests of fibrosis and hepatic inflammation

Shared decision-making between the patient and their care team is indicated to decide whether to start, continue or discontinue GLP-1 therapy in the setting of a new diagnosis of NAION or in certain risk contexts, considering the individual patient characteristics and clinical scenario, the guidance article authors wrote

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The answer was Nomio, already widespread across Nordic skiing in Europe, and now spreading through cycling and running